← FDA Medical Device Classifications
Device, Incontinence, Urosheath Type, Sterile
EXJ · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.5250
Classification
- FDA Product Code
EXJ- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 876.5250
- Review panel
- GU
- Medical specialty
- Gastroenterology, Urology
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Market data
- Cleared 510(k) submissions
- 22
- Registered establishments
- 12
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown